This week’s Endocrinology update covers guideline and labeling changes, regulatory milestones for devices, and new research spanning genetics, AI-enabled prevention, and mechanistic biology.
In Today’s Newsletter
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⚖️ AstraZeneca blocks Pharmacor dapagliflozin generics (Forxiga) [1] [AU • 17 Feb 2026]
https://finance.yahoo.com/news/inside-biotech-astrazeneca-halts-generic-051000429.html
Context: Federal Court of Australia interlocutory stage, patent AU 2003237886 cited as expiring 22 Oct 2027. [1]
Key point: Court granted an interlocutory injunction restraining Pharmacor from selling dapagliflozin products, also requiring changes to PBS listing steps, pending a full trial. [1]
Implication: Introduces competition that may affect pricing and formulary access.
🧭 NICE recommends metformin plus SGLT2 inhibitor as initial therapy in type 2 diabetes [2] [UK • 18 Feb 2026]
https://www.pharmacymagazine.co.uk/news/nice-recommends-flozins-first-line-for-type-2-diabetes
Context: NICE pathway update, also references GLP-1 receptor agonists and tirzepatide for specified groups. [2]
Key point: NICE now recommends modified-release metformin plus an SGLT2 inhibitor as initial therapy (rather than metformin alone for most). [2]
Implication: May influence prescriber choice and payer reviews pending full data.
🏷️ FDA updates menopausal hormone therapy labels, removes certain boxed-warning statements [3] [US • 22 Feb 2026]
Context: Report says FDA began the process in Nov 2025 and approved first group of changes for six products. [3]
Key point: Risk statements related to cardiovascular disease, breast cancer, and probable dementia were removed from the boxed warning for six products (per report). [3]
Implication: May influence prescriber choice and payer reviews pending full data.
🩺 Portal Diabetes gets FDA Breakthrough Device designation for implantable insulin pump system [4] [US • 18 Feb 2026]
Context: Source describes an implantable pump plus CGM plus concentrated insulin concept, and notes early Phase I activity (first two patients) for its insulin program. [4]
Key point: Portal Diabetes reported FDA Breakthrough Device designation for its implantable pump system, facilitating priority FDA engagement (per report). [4]
Implication: May expand screening, initiation, and follow-up at scale.
🧠 Lifestyle, stress, and AI are shaping diabetes management in the Middle East (interview) [5] [19 Feb 2026]
Context: Interview discusses lifestyle interventions, stress physiology, and examples of AI tools in clinics (retinal screening, CGM predictions). [5]
Key point: Expert commentary emphasizes lifestyle change and describes emerging AI-enabled screening and monitoring workflows (outcomes not stated). [5]
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Childhood BMI changes genetically linked to adulthood diabetes and heart disease (UQ, ALSPAC) [6] [AU • 20 Feb 2026]
Context: Modelling study using ALSPAC data, 6,291 children ages 1–18, published in Nature Communications (per report). [6]
Key point: Report says genetics contribute to BMI patterns over time, and BMI around age 10 plus growth rate from 1–18 may be linked to later diabetes and cardiovascular risk. [6]
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🤖 PRAESIIDIUM physics-informed AI for prediabetes prevention (SUPSI) [7] [EU • 18 Feb 2026]
Context: Horizon Europe project described as completed, integrating clinical and wearable data (per report). [7]
Key point: Project reports physics-informed ML models embedding physiological knowledge for early prediabetes risk prediction, integrated into a research platform (per report). [7]
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧫 Low oxygen, red blood cells, and glucose lowering (Reuters Health Rounds) [8] [20 Feb 2026]
Context: Reuters cites a Cell Metabolism report and mouse experiments under low-oxygen conditions. [8]
Key point: Source reports red blood cells take up more glucose in low oxygen, and a candidate drug (HypoxyStat) reversed high blood sugar in diabetic mice (human data not stated). [8]
Implication: May influence prescriber choice and payer reviews pending full data.
Why It Matters
- NICE guidance can shift UK prescribing and commissioning decisions for SGLT2 inhibitors and adjacent classes. [2]
- FDA boxed-warning edits may change counseling language and perceptions of menopausal hormone therapy. [3]
- Breakthrough Device status can speed FDA engagement, but adoption still depends on clinical evidence and workflow fit. [4]
- Genetics and AI prevention tools are expanding, but translation depends on validation, bias control, and implementation. [6–7]
- Mechanistic mouse findings are hypothesis-generating, not practice-changing without human trials. [8]
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FAQ
What did the AstraZeneca–Pharmacor ruling do in Australia?
It granted an interlocutory injunction stopping Pharmacor from selling dapagliflozin products and requiring PBS listing steps to be withdrawn or adjusted, pending a full trial (per report). [1]
What changed in NICE’s first-line treatment for type 2 diabetes?
NICE now recommends modified-release metformin plus an SGLT2 inhibitor as initial therapy, rather than metformin alone for most newly diagnosed people (per report). [2]
Did FDA “remove risks” from menopausal hormone therapy?
The report says certain risk statements were removed from boxed warnings for six products, it does not state that risks are absent. [3]
Is Portal Diabetes’s implantable pump FDA-approved?
The source describes Breakthrough Device designation and ongoing development, it is not described as authorized for sale. [4]
Is HypoxyStat a diabetes treatment available now?
No. Reuters reports results in diabetic mice and a proposed mechanism, with no human efficacy stated. [8]
Entities / Keywords
AstraZeneca, Forxiga, dapagliflozin, Pharmacor, PBS, AU 2003237886; NICE, modified-release metformin, SGLT2 inhibitors (flozins), GLP-1 receptor agonists, tirzepatide; FDA, menopausal hormone therapy, boxed warning, estrogen, progestogen; Portal Diabetes, Portal Pump, implantable insulin pump, intraperitoneal insulin, CGM; Middle East diabetes care, stress, AI retinal screening, AI-augmented CGM; University of Queensland, ALSPAC (Children of the 90s), BMI trajectories, genetics; PRAESIIDIUM, physics-informed ML, SUPSI, Horizon Europe; low oxygen, red blood cells, glucose sink, HypoxyStat, Cell Metabolism.
